BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GS 777 WALL TRANSFORMER W/OPHTH & OTO UK

    MDR report key: 22931740 · Received September 2, 2025

    Report

    Report Number
    1316463-2025-00076
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 1, 2025
    Report Date
    September 1, 2025
    Manufacturer
    WELCH ALLYN INC.
    Product Code
    GCW
    UDI-DI
    00732094136722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED BY THE CUSTOMER SO INSPECTION COULD NOT BE PERFORMED TO DETERMINE A ROOT CAUSE OF THE REPORTED EVENT. PER THE TECHNICIAN, THERE WAS NO EVIDENCE TO SHOW WHAT CAUSED THE SPARKING. THE GREEN SERIES (GS) 777 WALL SYSTEM CONSISTS OF A WALL TRANSFORMER AND ACCESSORIES THAT CAN BE USED WITH IT. GS 777 WALL SYSTEM THE GREEN SERIES (GS) 777 WALL TRANSFORMER SUPPLIES POWER TO TWO CORDED, HANDLE-BASED RHEOSTATS. THE CUSTOMER CAN ATTACH VARIOUS OTOSCOPE AND OPHTHALMOSCOPE HEADS TO THE HANDLES. THE INTENSITY OF THE LIGHT PRODUCED BY THE HEADS IS CONTROLLED BY TWISTING THE RHEOSTAT. THE PRODUCT IS CONNECTED TO A 5-WATT POWER SUPPLY VIA A USB 2.0 MINI-B TO TWIN USB CABLE. ALTHOUGH THERE WAS NO ADVERSE EVENT REPORTED AND THE ROOT CAUSE COULD NOT BE CONFIRMED, IF THE AC PLUG WERE TO SPARK DURING USE, IT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THIS WERE TO RECUR.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE WALL SYSTEM'S TRANSFORMER PLUG HAS EVIDENCE OF SPARKING. BLACK SOOT ALL THROUGHOUT THE CONNECTOR BETWEEN THE PLUG BODY AND THE INBUILT UK PLUG SOCKET ADAPTER. THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2865995 GS 777 WALL TRANSFORMER W/OPHTH & OTO UK TRANSFORMER, ENDOSCOPE GCW WELCH ALLYN INC. 77754 00732094136722

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown